Innovent has expanded its global Phase III MarsLight-11 trial to add non-squamous NSCLC patients. The new substudy will enroll patients with advanced or metastatic disease that progressed after chemotherapy and immunotherapy; IBI363 monotherapy will be compared with docetaxel.
With the expansion, the multicentre, randomised, controlled trial has separate substudies for squamous and non-squamous NSCLC. IBI363, also known as TAK-928, blocks the PD-1/PD-L1 pathway and selectively activates the IL-2 pathway; targeted binding to specific IL-2 receptors is intended to reduce toxicity. Innovent and Takeda are co-developing it globally.
IBI363/TAK-928 has received two fast track designations from the US FDA and three breakthrough therapy designations from China's NMPA.
